NCT04306432

Brief Summary

This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
97mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2019Mar 2034

Study Start

First participant enrolled

January 3, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2034

Last Updated

December 2, 2021

Status Verified

May 1, 2021

Enrollment Period

15.2 years

First QC Date

March 10, 2020

Last Update Submit

November 19, 2021

Conditions

Primary Brain TumourRadiation ToxicityCognitive Impairment

Keywords

Brain tumourRadiation therapyCognitive functionHippocampusPatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Impairment of verbal learning and memory as assessed by the HVLT-r test

    Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)

    10 Years

Secondary Outcomes (13)

  • Processing speed I

    10 years

  • Processing speed II

    10 years

  • Attention and working memory

    10 years

  • Verbal learning and memory

    10 years

  • Verbal fluency

    10 years

  • +8 more secondary outcomes

Interventions

Cognitive tests and Patient Reported OutcomesOTHER

Each patient will undergo cognitive tests and questionnaires

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.

You may qualify if:

  • years or older and Danish speaking.
  • Performance status WHO 0-2
  • Capable of cooperating on testing
  • Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

You may not qualify if:

  • Glioblastoma
  • Performance status 3-4 (Karnofsky Performances of 60 or less)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Oncology, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Danish Center for Particel Therapy

Aarhus, Region Midt, 8200, Denmark

RECRUITING

Department of Oncology, Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

RECRUITING

Department of Oncology, Aalborg University Hospital

Aalborg, Region Nord, 9000, Denmark

RECRUITING

Department of Oncology, Odense University Hospital

Odense, Region Syd, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Radiation InjuriesCognitive DysfunctionBrain Neoplasms

Interventions

Neuropsychological TestsPatient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Wounds and InjuriesCognition DisordersNeurocognitive DisordersMental DisordersCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesHealth Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Lene Haldbo-Classen, M.D

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Høyer, MD

CONTACT

+45 2328 2823morthoey@rm.dk

Lene Haldbo-Classen, MD

CONTACT

+4523342761lenhaldb@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

January 3, 2019

Primary Completion (Estimated)

March 31, 2034

Study Completion (Estimated)

March 31, 2034

Last Updated

December 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)